Section 866.2540 - Microbiological incubator(a)Identification. A microbiological incubator is a device with various chambers or water-filled compartments in which controlled environmental conditions, particularly temperature, are maintained. It is intended for medical purposes to cultivate microorganisms and aid in the diagnosis of disease.(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9 . The device is also exempt from the good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 , with respect to general requirements concerning records, and § 820.198 , with respect to complaint files.47 FR 50823, Nov. 9, 1982, as amended at 66 FR 38791 , July 25, 2001